DR. PIYUSH GUPTA (MBBS, MBA)
ASSOCIATE DIRECTOR – BUSINESS DEVELOPMENT
IN THIS PRESENTATION
- Era Of Bio Therapuetics
- Reverse Planning
- Significance Of Source Markets
- Effects On Registration, Costs And Time To Market
- Key points in sourcing Bio-similar
- Comparator Souring Organisation – Roles and Services.
1. ERA OF BIOTHERAPUTICS
- Conventional Medication has been used and abused by Humanity for over a century now
- Human body has started becoming immune to conventional medication
- Antibiotic resistance is at it’s all time high
- The next frontier in medicines is Bio-Therapeutics Targeting of Cells at DNA and Gene level
2. REVERSE PLANNING
- What is Reverse planning ?
- Conventional RnD approach do not work for Bio-similars development
- Bio-similars are expensive to develop, clinical studies are more complex and Stability even more so.
- Top down approach of planning the full RnD process, Trials, Studies and then looking for Comparators has led to looses of Millions of Dollors in:
- Excess stock
- Expired Stock
- Wrong Packs
- Reverse Planning:
- Start by identifying your Destination Markets
- For Example a Bio-similar to be registered in EU needs a EU sourced comparator from Innovator with EU number of the pack.
- While a Bio-similar for registration in RoW markets will accept comparator from any markets as long as it’s from the innovator.
- This reverse planning can SAVE millions of Dollars in sourcing by selecting the right source markets.
3. Signiﬁcance of Source Markets
- Source Markets should be chosen based on your Destination markets
- For Example if you plan to Target RoW Markets, there’s no point in souring products from US market
- US products with NDC numbers are at least 3 time more expensive as compared to same brand in International packs
- US stocks are difﬁcult to get, highly controlled, traced and the sheer cost makes the development process un-viable.
- In contrast to this : An International pack from Europe / Eastern Europe is available at 1/3rd the cost, in Large quantities and with Pedigree Documents.
4. Effects on Registration
- Ultimate goal of any development is to SELL the product
- Sell – Fast and First to Market
- Sell – At Most competitive price
- Example : India is a Right Hand Drive Country – Is there any point launching a Left Hand Drive Car here ?
- Similarly if your destination is RoW – there’s no point in Sourcing of US / EU stock for RnD
- Lack of reverse planning : Only increase development cost hence the END product COST
- Lack of product availability from US / EU markets – delays development
- And off course you are not FAST or First to market
5.Key points in Sourcing Bio-Similars
- Identify your Destination Markets First
- Check availability, Pack descriptions, SPC etc… of your comparator in planning stage
- Call for Pack photos, Pack Scans in planning stage
- Estimate the Quantity, Frequency etc…. in advance
- Understand availability issues for Comparators right in the beginning.
- Tie up your source even before you start development process
6. CSO – Comparator Sourcing Organisation
- While Development and RnD is the a focus of Manufacturers or CROs
- Sourcing of Innovators / Comparators can be big challenge
- An ideal CSO should be :
- WHO GDP Certiﬁed Site
- With validated Storage and Shipping systems
- With Global Reach
- Ability to source and transport products world wide
- Knowledgable about Global Market place
- In depth Experience in Sourcing, Imports and Exports
GNH India – 1st CSO in India
- A WHO GDP certiﬁed by SGS India
- DFGT recognised Export house
- Over 12 years of Industry Experience
- Qualiﬁed QP on site in Warehouse
- Fully licensed by State FDA and DGFT to carry imports and Exports of Drugs and related products
- Over 135,000 products
GNH India – 1st CSO in India
- Shipping and importing Globally to over 180 countries
- Validated Storage and Shipping systems
- Full Traceability and Pedigree for every supply
- In Depth Market knowledge and Market intelligence
- Complete Regulatory and compliance support up-till Market launch
Market Intelligence – 1 product – 2 packs ??